- GNC (Greenville, SC)
- …Application Security, Data Security, Infrastructure Security, Software Security Practices, Compliance to FDA 's Computer Systems Validation Code (21 CFR Part ... external stakeholders. + Subject Matter Expert in Good Manufacturing Practice Regulations, FDA Labeling regulations, CPSC and USDA regulations as applied to Foods… more
- Boehringer Ingelheim (Athens, GA)
- …reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist, Validation manages all phases of higher level, more complex validation ... project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's Validation … more
- Catalent Pharma Solutions (Harmans, MD)
- ** Computer Systems Validation Engineer** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... MD is hiring an Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
- Robert Half Technology (New Haven, CT)
- …knowledge and skills in GxP and GxP FDA . * Proficiency in handling Computer Systems and System Validation . * Experience in Compliance Risk management related ... Description We are offering an exciting opportunity for a Computer Systems Validation Specialist in New Haven...to IT systems. * Familiarity with FDA 21 CFR regulations and guidelines. * Expertise in… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- Astrix Technology (St. Joseph, MO)
- ** Computer System Validation Engineer** Engineering Saint Joseph, MO, US Pay Rate Low: 80.00 | Pay Rate High: 85.00 + Added - 09/01/2025 Apply for Job We are ... seeking a Senior Computer System Validation (CSV) Engineer to play...healthcare industry. + In-depth understanding of GxP regulations (eg, FDA 21 CFR Part 11, EU Annex 11). #INDBH… more
- J&J Family of Companies (Danvers, MA)
- Johnson & Johnson Abiomed is recruiting for a Staff Computer System Validation (CSV) Engineer. This position can be based at any Abiomed site in the United ... provide SME support at Abiomed. + Develop and execute validation plans for new and existing GxP computer...other relevant regulatory requirements such as ISO 13485, 82304, FDA CSA Draft Guidance + Excellent analytical and problem-solving… more
- Boehringer Ingelheim (St. Joseph, MO)
- …of validation of biopharmaceutical processes, equipment, utilities, facilities, cleaning validation , and USDA and FDA /EU regulations. + * Excellence in ... comprehension/application of USDA and FDA /EU regulatory requirements for validation /qualification of equipment/process/cleaning...detail. + * This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for… more
- Fujifilm (College Station, TX)
- …preferably in FDA -regulated environment. + Associate of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 7+ years of ... experience in pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environment, OR; + Bachelor's Degree and 5+ years...experience in computer system validation activities in pharmaceutical, biotechnology,… more
- Unither Pharmaceuticals (Rochester, NY)
- Validation Technician Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify ... Your role Reporting to the Quality Director, JOB SUMMARY: Assists validation efforts in many ways including the following: executes/supports equipment, cleaning,… more
- Charles River Laboratories (Newark, DE)
- …related field. **Experience:** ⦁ Minimum of 1-2 years experience in a computer system validation or software testing within pharmaceutical, biotechnology, ... you can feel passionate about. **Job Summary** Develop and manage validation and qualification activities associated with computerized systems to ensure compliance… more
- Sokol Materials & Services (Skillman, NJ)
- CSV Validation Engineer Mid-Level Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1) Job Location Job Type Workspace Skillman, NJ ... Validation Engineer On-site position (no remote or hybrid options)...Education and Experience : + Bachelor's degree in engineering, computer science, or a related field (required). + Minimum… more
- Curia (Burlington, MA)
- … validation and revalidation protocols for processes, equipment, utility, and computer software validation . Work with Engineering and Facilities personnel to ... Validation tools and processes, which include waterfall, validation life cycle, and V-Model; * FDA ...waterfall, validation life cycle, and V-Model; * FDA regulations and Good Documentation Practices (GDP) related to… more
- Bio-Techne (St. Paul, MN)
- …Bring your talent to our Bio-Techne! We are seeking an Advanced Quality Validation Engineer with experience in GMP qualification and validation . This position ... a dynamic team with diverse experiences/backgrounds. You will support with qualification / validation activities leading to new product launches. Quality is one thing… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …science or engineering field with 0 years of experience in implementation and validation of manufacturing equipment and associated computer systems + Associate ... Degree with 2+ years of validation experience in implementation and validation of manufacturing equipment and associated computer systems + High School… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as Facilities, Utilities and Equipment, Cleaning (CIP/COP), Sterilization (Autoclaves & SIPs), Computer System Validation (PCS/PAS, BMS, CMS, DeltaV, OSI Pi, ... engineering, or any combination thereof. + Demonstrate basic experience in validation disciplines (equipment, facilities, critical systems, computer , cleaning,… more
- Curia (Albuquerque, NM)
- …and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), environmental ... mapping and use of Kaye Validator + Experience with FDA and EU regulations for pharmaceuticals and validation...form and deal with several abstract and concrete variables. Computer Skills: The ideal candidate will possess a strong… more
- Actalent (Irvine, CA)
- … + Validation protocols + Pharmaceutical + Validation testing + Equipment validation + Computer system validation + Technical writing + Process ... **Immediate Validation Engineering Opportunity** **For Immediate Consideration please apply...Pharmaceutical Manufacturing and Quality Control. + Expertise in US FDA cGMPs as well as comparable international regulatory agency… more
- Sokol Materials & Services (Skillman, NJ)
- …risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: + Proficient in ... CQV Validation Engineer Mid-Level Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1) Job Location...Physical Requirements : + Prolonged periods of sitting and computer use. + Must be able to lift up… more
- Sokol Materials & Services (Skillman, NJ)
- CQV Validation Engineer Lead Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1) Job Location Job Type Workspace Skillman, NJ ... Validation Engineer On-site position (no remote or hybrid options)... principles, methodologies, and risk-based approaches, including familiarity with FDA , EMA, and ICH guidelines. + Proven leadership abilities… more
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